--- title: "De Novo & Breakthrough Pathways - Learning Path - MedTech Terms" description: "Novel and expedited FDA pathways for devices with no predicate or that address unmet needs, plus Q-Submission and Pre-Submission mechanics." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": [ "Course", "LearningResource" ], "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course", "name": "De Novo & Breakthrough Pathways", "description": "Novel and expedited FDA pathways for devices with no predicate or that address unmet needs, plus Q-Submission and Pre-Submission mechanics.", "url": "https://medtechterms.com/paths/de-novo-and-breakthrough", "courseCode": "de-novo-and-breakthrough", "educationalLevel": "Professional", "learningResourceType": "Curriculum", "inLanguage": "en", "teaches": [ "De Novo Classification Request", "Breakthrough Device Designation", "Pre-Submission Meeting", "Q-Submission (Pre-Submission)", "Intended Use", "Indications for Use", "Predicate Device", "Substantial Equivalence", "510(k) Premarket Notification", "Premarket Approval", "Combination Product" ], "about": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/de-novo#term", "name": "De Novo Classification Request", "alternateName": "De Novo", "url": "https://medtechterms.com/terms/de-novo" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/breakthrough-device#term", "name": "Breakthrough Device Designation", "alternateName": "BDD", "url": "https://medtechterms.com/terms/breakthrough-device" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pre-submission#term", "name": "Pre-Submission Meeting", "alternateName": "Q-Sub", "url": "https://medtechterms.com/terms/pre-submission" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/q-sub#term", "name": "Q-Submission (Pre-Submission)", "alternateName": "Q-Sub / Pre-Sub", "url": "https://medtechterms.com/terms/q-sub" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/intended-use#term", "name": "Intended Use", "url": "https://medtechterms.com/terms/intended-use" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/indications-for-use#term", "name": "Indications for Use", "alternateName": "IFU (statement)", "url": "https://medtechterms.com/terms/indications-for-use" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/predicate-device#term", "name": "Predicate Device", "url": "https://medtechterms.com/terms/predicate-device" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/substantial-equivalence#term", "name": "Substantial Equivalence", "alternateName": "SE", "url": "https://medtechterms.com/terms/substantial-equivalence" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma#term", "name": "Premarket Approval", "alternateName": "PMA", "url": "https://medtechterms.com/terms/pma" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/combination-product#term", "name": "Combination Product", "url": "https://medtechterms.com/terms/combination-product" } ], "audience": { "@type": "EducationalAudience", "educationalRole": "RA · Startup · Product" }, "provider": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com", "sameAs": [ "https://bluegoatcyber.com" ] }, "offers": { "@type": "Offer", "price": "0", "priceCurrency": "USD", "category": "Free", "availability": "https://schema.org/InStock" }, "hasCourseInstance": { "@type": "CourseInstance", "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#instance", "courseMode": "Online", "courseWorkload": "PT55M", "inLanguage": "en", "instructor": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://medtechterms.com/authors/christian-espinosa" } }, "hasPart": [ { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/de-novo#lesson-de-novo-and-breakthrough", "name": "De Novo Classification Request", "url": "https://medtechterms.com/terms/de-novo", "learningResourceType": "Lesson", "inLanguage": "en", "description": "The pathway for novel low- to moderate-risk devices with no predicate.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/de-novo#term", "name": "De Novo Classification Request", "alternateName": "De Novo", "url": "https://medtechterms.com/terms/de-novo" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/breakthrough-device#lesson-de-novo-and-breakthrough", "name": "Breakthrough Device Designation", "url": "https://medtechterms.com/terms/breakthrough-device", "learningResourceType": "Lesson", "inLanguage": "en", "description": "Designation that unlocks expedited FDA interaction, not a separate submission type.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/breakthrough-device#term", "name": "Breakthrough Device Designation", "alternateName": "BDD", "url": "https://medtechterms.com/terms/breakthrough-device" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/pre-submission#lesson-de-novo-and-breakthrough", "name": "Pre-Submission Meeting", "url": "https://medtechterms.com/terms/pre-submission", "learningResourceType": "Lesson", "inLanguage": "en", "description": "The most valuable free tool FDA offers: written feedback before you file.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pre-submission#term", "name": "Pre-Submission Meeting", "alternateName": "Q-Sub", "url": "https://medtechterms.com/terms/pre-submission" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/q-sub#lesson-de-novo-and-breakthrough", "name": "Q-Submission (Pre-Submission)", "url": "https://medtechterms.com/terms/q-sub", "learningResourceType": "Lesson", "inLanguage": "en", "description": "The umbrella program that contains Pre-Sub, Study Risk Determination, and more.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/q-sub#term", "name": "Q-Submission (Pre-Submission)", "alternateName": "Q-Sub / Pre-Sub", "url": "https://medtechterms.com/terms/q-sub" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/intended-use#lesson-de-novo-and-breakthrough", "name": "Intended Use", "url": "https://medtechterms.com/terms/intended-use", "learningResourceType": "Lesson", "inLanguage": "en", "description": "The single sentence that anchors your whole regulatory strategy.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/intended-use#term", "name": "Intended Use", "url": "https://medtechterms.com/terms/intended-use" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/indications-for-use#lesson-de-novo-and-breakthrough", "name": "Indications for Use", "url": "https://medtechterms.com/terms/indications-for-use", "learningResourceType": "Lesson", "inLanguage": "en", "description": "The clinical situations your device is labeled for; drives evidence requirements.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/indications-for-use#term", "name": "Indications for Use", "alternateName": "IFU (statement)", "url": "https://medtechterms.com/terms/indications-for-use" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/predicate-device#lesson-de-novo-and-breakthrough", "name": "Predicate Device", "url": "https://medtechterms.com/terms/predicate-device", "learningResourceType": "Lesson", "inLanguage": "en", "description": "Why De Novo exists: what you file when no acceptable predicate is available.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/predicate-device#term", "name": "Predicate Device", "url": "https://medtechterms.com/terms/predicate-device" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/substantial-equivalence#lesson-de-novo-and-breakthrough", "name": "Substantial Equivalence", "url": "https://medtechterms.com/terms/substantial-equivalence", "learningResourceType": "Lesson", "inLanguage": "en", "description": "The 510(k) test you cannot meet, which is why you're reading this path.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/substantial-equivalence#term", "name": "Substantial Equivalence", "alternateName": "SE", "url": "https://medtechterms.com/terms/substantial-equivalence" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/510k#lesson-de-novo-and-breakthrough", "name": "510(k) Premarket Notification", "url": "https://medtechterms.com/terms/510k", "learningResourceType": "Lesson", "inLanguage": "en", "description": "Compare to see why De Novo is different in evidence and outcome.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/pma#lesson-de-novo-and-breakthrough", "name": "Premarket Approval", "url": "https://medtechterms.com/terms/pma", "learningResourceType": "Lesson", "inLanguage": "en", "description": "Where you end up if FDA decides your device belongs in Class III instead.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma#term", "name": "Premarket Approval", "alternateName": "PMA", "url": "https://medtechterms.com/terms/pma" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } }, { "@type": "LearningResource", "@id": "https://medtechterms.com/terms/combination-product#lesson-de-novo-and-breakthrough", "name": "Combination Product", "url": "https://medtechterms.com/terms/combination-product", "learningResourceType": "Lesson", "inLanguage": "en", "description": "Extra Center-assignment step for device + drug or device + biologic products.", "about": { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/combination-product#term", "name": "Combination Product", "url": "https://medtechterms.com/terms/combination-product" }, "isPartOf": { "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#course" } } ] }, { "@type": "ItemList", "@id": "https://medtechterms.com/paths/de-novo-and-breakthrough#itemlist", "name": "De Novo & Breakthrough Pathways", "itemListOrder": "https://schema.org/ItemListOrderAscending", "numberOfItems": 11, "itemListElement": [ { "@type": "ListItem", "position": 1, "url": "https://medtechterms.com/terms/de-novo", "name": "De Novo Classification Request", "description": "The pathway for novel low- to moderate-risk devices with no predicate." }, { "@type": "ListItem", "position": 2, "url": "https://medtechterms.com/terms/breakthrough-device", "name": "Breakthrough Device Designation", "description": "Designation that unlocks expedited FDA interaction, not a separate submission type." }, { "@type": "ListItem", "position": 3, "url": "https://medtechterms.com/terms/pre-submission", "name": "Pre-Submission Meeting", "description": "The most valuable free tool FDA offers: written feedback before you file." }, { "@type": "ListItem", "position": 4, "url": "https://medtechterms.com/terms/q-sub", "name": "Q-Submission (Pre-Submission)", "description": "The umbrella program that contains Pre-Sub, Study Risk Determination, and more." }, { "@type": "ListItem", "position": 5, "url": "https://medtechterms.com/terms/intended-use", "name": "Intended Use", "description": "The single sentence that anchors your whole regulatory strategy." }, { "@type": "ListItem", "position": 6, "url": "https://medtechterms.com/terms/indications-for-use", "name": "Indications for Use", "description": "The clinical situations your device is labeled for; drives evidence requirements." }, { "@type": "ListItem", "position": 7, "url": "https://medtechterms.com/terms/predicate-device", "name": "Predicate Device", "description": "Why De Novo exists: what you file when no acceptable predicate is available." }, { "@type": "ListItem", "position": 8, "url": "https://medtechterms.com/terms/substantial-equivalence", "name": "Substantial Equivalence", "description": "The 510(k) test you cannot meet, which is why you're reading this path." }, { "@type": "ListItem", "position": 9, "url": "https://medtechterms.com/terms/510k", "name": "510(k) Premarket Notification", "description": "Compare to see why De Novo is different in evidence and outcome." }, { "@type": "ListItem", "position": 10, "url": "https://medtechterms.com/terms/pma", "name": "Premarket Approval", "description": "Where you end up if FDA decides your device belongs in Class III instead." }, { "@type": "ListItem", "position": 11, "url": "https://medtechterms.com/terms/combination-product", "name": "Combination Product", "description": "Extra Center-assignment step for device + drug or device + biologic products." } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Learning Paths", "item": "https://medtechterms.com/paths" }, { "@type": "ListItem", "position": 3, "name": "De Novo & Breakthrough Pathways", "item": "https://medtechterms.com/paths/de-novo-and-breakthrough" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All paths](/paths)RA · Startup · Product · 11 terms # De Novo & Breakthrough Pathways Novel and expedited FDA pathways for devices with no predicate or that address unmet needs, plus Q-Submission and Pre-Submission mechanics. Your progress 0 of 11 lessons complete · up next: De Novo Classification Request [Start path](/terms/de-novo?from=de-novo-and-breakthrough) 1. 1 [ Regulatory ## De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. Why this term here: The pathway for novel low- to moderate-risk devices with no predicate. ](/terms/de-novo?from=de-novo-and-breakthrough)Mark done 2. 2 [ Regulatory ## Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. Why this term here: Designation that unlocks expedited FDA interaction, not a separate submission type. ](/terms/breakthrough-device?from=de-novo-and-breakthrough)Mark done 3. 3 [ Commercialization ## Pre-Submission Meeting(Q-Sub) Formal FDA feedback request prior to a marketing or IDE submission. Why this term here: The most valuable free tool FDA offers: written feedback before you file. ](/terms/pre-submission?from=de-novo-and-breakthrough)Mark done 4. 4 [ Regulatory ## Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) Voluntary mechanism to obtain FDA feedback before a formal premarket submission. Why this term here: The umbrella program that contains Pre-Sub, Study Risk Determination, and more. ](/terms/q-sub?from=de-novo-and-breakthrough)Mark done 5. 5 [ Regulatory ## Intended Use The objective intent of the manufacturer regarding the use of the device. Why this term here: The single sentence that anchors your whole regulatory strategy. ](/terms/intended-use?from=de-novo-and-breakthrough)Mark done 6. 6 [ Regulatory ## Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. Why this term here: The clinical situations your device is labeled for; drives evidence requirements. ](/terms/indications-for-use?from=de-novo-and-breakthrough)Mark done 7. 7 [ Regulatory ## Predicate Device A legally marketed device used as the comparator in a 510(k) submission. Why this term here: Why De Novo exists: what you file when no acceptable predicate is available. ](/terms/predicate-device?from=de-novo-and-breakthrough)Mark done 8. 8 [ Regulatory ## Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. Why this term here: The 510(k) test you cannot meet, which is why you're reading this path. ](/terms/substantial-equivalence?from=de-novo-and-breakthrough)Mark done 9. 9 [ Regulatory ## 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. Why this term here: Compare to see why De Novo is different in evidence and outcome. ](/terms/510k?from=de-novo-and-breakthrough)Mark done 10. 10 [ Regulatory ## Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. Why this term here: Where you end up if FDA decides your device belongs in Class III instead. ](/terms/pma?from=de-novo-and-breakthrough)Mark done 11. 11 [ Regulatory ## Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. Why this term here: Extra Center-assignment step for device + drug or device + biologic products. ](/terms/combination-product?from=de-novo-and-breakthrough)Mark done Finished the path? Test yourself with a quiz tailored to these 11 terms. [Take the De Novo & Breakthrough Pathways quiz](/quiz?path=de-novo-and-breakthrough) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)